PMA P010012S300
- Device
- COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S300
- Product code
- LWP
- Decision date
- 2012-11-30
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES.
Current openFDA PMA Record#
- Device
- COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S300
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-11-30
- Decision code
- APPR
- Date received
- 2012-08-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES.